Agency Information Collection Activities: Proposed Collection; Comment Request, 24957-24959 [2012-10009]

Download as PDF 24957 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices TABLE 3—COST TO THE FEDERAL GOVERNMENT—Continued Cost component Total cost Annualized cost Government Oversight ............................................................................................................................................. 13,710 4,570 Total .................................................................................................................................................................. 499,877 166,626 Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: April 19, 2012. Carolyn M. Clancy, Director. Proposed Project [FR Doc. 2012–10007 Filed 4–25–12; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ‘‘American Recovery and Reinvestment Act ‘‘Developing a Registry of Registries’’.’’ In accordance with the tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:51 Apr 25, 2012 Paperwork Reduction Act, 44 U.S.C. 3501–3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 23, 2012 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by May 29, 2012. ADDRESSES: Written comments should be submitted to: AHRQ’s OMB Desk Officer by fax at (202) 395–6974 (attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov (attention: AHRQ’s desk officer). Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at doris.lefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: Jkt 226001 American Recovery and Reinvestment Act ‘‘Developing a Registry of Registries’’ The Food and Drug Administration Modernization Act of 1997, Public Law 105–115, provided for the creation of a Clinical Trials Data Bank, known as ClinicalTrials.gov. Since its launch in 2000, the ClinicalTrials.gov system has registered over 90,500 trials. The large volume of studies currently listed in ClinicalTrials.gov and the high usage numbers suggest that the system has been successful at improving access to information about clinical studies. However, while ClinicalTrials.gov supports the listing of observational studies, such listing is not required. Patient registries are a distinct type of observational study. Patient registries may be designed for many purposes, such as to observe the natural history of disease, examine comparative effectiveness, or fulfill post-approval commitments. Patient registries have specific characteristics that are not PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 currently captured on ClinicalTrials.gov. To date, some registry sponsors have attempted to leverage the observational study model to post patient registry-type records on ClinicalTrials.gov. However, stakeholders have noted that the system does not fully meet their needs. Patient registries have received significant attention and funding in recent years. Similar to controlled interventional studies, patient registries represent some burden to patients (e.g., time to complete patient reported outcome measures, risk of loss of privacy), who often participate voluntarily in hopes of improving knowledge about a disease or condition. Patient registries also represent a substantial investment of health research resources. Despite these factors, registration of patient registries in ClinicalTrials.gov is not currently required, presenting the potential for duplication of efforts and insufficient dissemination of findings that are not published in the peer-reviewed literature. To ensure that resources are used in the most efficient manner, registries need to be listed in a manner similar to that of trials in ClinicalTrials.gov. By creating a central point of collection for information about all patient registries in the United States, the Registry of Patient Registries (RoPR) helps to further AHRQ’s goals by making information regarding quality, appropriateness, and effectiveness of health services (and patient registries in particular) more readily available and centralized. The primary goal of this project is to engage stakeholders in the design and development of a RoPR database system that is compatible with ClinicalTrials.gov and meets the following objectives: (1) Provides a searchable database of patient registries in the United States (to promote collaboration, reduce redundancy, and improve transparency); (2) Facilitates the use of common data fields and definitions in similar health conditions (to improve opportunities for sharing, comparing, and linkage); (3) Provides a public repository of searchable summary results (including E:\FR\FM\26APN1.SGM 26APN1 24958 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices results from registries that have not yet been published in the peer-reviewed literature); (4) Offers a search tool to locate existing data that researchers can request for use in new studies; and serves as a recruitment tool for researchers and patients interested in participating in patient registries. This study is being conducted by AHRQ through its contractor, the Outcome DEcIDE Center, pursuant to the American Recovery and Reinvestment Act, Public Law 111–5, and pursuant to AHRQ’s statutory authority to conduct and support research and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to database development. 42 U.S.C. 299a(a)(1) and (8). Method of Collection To achieve the goals of this project the following data collections will be implemented: (1) Collect information from registry holders, defining a patient registry profile via a web-based interface, to populate the RoPR database system. The purpose of the RoPR is to create a readily available public resource in the model of ClinicalTrials.gov to share information on existing patient registries to promote collaboration, reduce redundancy, and improve transparency in registry research. Patient registry research has become more prevalent and, based on stakeholder feedback, is not adequately served by ClinicalTrials.gov at present. The information being collected in the RoPR record will be visible to the public visiting the RoPR Web site and will be available for public use in this capacity. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden for the respondents’ time to participate in the RoPR. Because the RoPR is a voluntary system available to any entity conducting a patient registry, it is not possible to determine the number of potential respondents. We do know that over 3,800 newly registered records designated as ‘‘observational studies’’ were entered into ClinicalTrials.gov in 2010. Only a subset of this number (which we will estimate at a maximum of 40%) would qualify as patient registries and would likely be registered in the RoPR. Therefore, we use 1,520 (3,800*0.40) in Exhibits 1 and 2 below as a very rough, but high, estimation of the potential number of respondents who will enter registries into the RoPR annually. The actual number of respondents will depend on a variety of factors and could vary widely. It should be remembered that mandates could evolve making registration in the RoPR mandatory. Our estimates therefore attempt to factor an upper threshold for volume. Each respondent will enter a new RoPR record only once and is estimated to take 45 minutes. An estimated 50% (760 records) of RoPR records will be updated once a year and will take about 15 minutes. This estimate is based on a query of ClinicalTrials.gov which showed that about 50% of observational studies registered in ClinicalTrials.gov had been updated in the past year. The total respondent burden is estimated to be 1,330 hours annually. Exhibit 2 shows the estimated cost burden associated with the respondent’s time to participate in the RoPR. The total cost burden is estimated to be $45,579 annually. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Number of responses per respondent Hours per response Total burden hours New RoPR Record .......................................................................................... Review/update RoPR Record .......................................................................... 1,520 760 1 1 45/60 15/60 1,140 190 Total .......................................................................................................... 2,280 na na 1,330 EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of espondents Form Name Total burden hours Average hourly rate + Total cost burden New RoPR Record .......................................................................................... Review/update RoPR Record .......................................................................... 1,520 760 1,140 190 $34.27 34.27 $39,068 6,511 Total .......................................................................................................... 2,280 1,330 na $45,579 + Based upon the mean average wage for Healthcare Practitioners and Technical Occupations, May 2010 National Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of Labor Statistics. Available at: http://www.bls.gov/oes/current/oes_nat.htm#29–0000. Estimated Annual Costs to the Federal Government tkelley on DSK3SPTVN1PROD with NOTICES Exhibit 3 shows the estimated total and annualized cost to the government to create and maintain the RoPR for 3 years. The total cost is estimated to be $3,184,333. EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST Cost component Total cost Project Development ............................................................................................................................................... Project Management ................................................................................................................................................ Overhead ................................................................................................................................................................. VerDate Mar<15>2010 17:51 Apr 25, 2012 Jkt 226001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\26APN1.SGM 26APN1 $2,318,509 409,149 456,675 Annualized cost $772,836 136,383 152,225 24959 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued Cost component Total cost Total .................................................................................................................................................................. Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: April 19, 2012. Carolyn M. Clancy, Director. [FR Doc. 2012–10009 Filed 4–25–12; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Local Therapies for Unresectable Primary Hepatocellular Carcinoma Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for scientific information submissions. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of local, minimally invasive, medical devices for unresectable primary hepatocellular carcinoma (e.g., ablation, radiotherapy, or embolization devices). Scientific information is being solicited to inform our Comparative Effectiveness Review tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:51 Apr 25, 2012 Jkt 226001 of Local Therapies for Unresectable Primary Hepatocellular Carcinoma, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173. DATES: Submission Deadline on or before May 29, 2012. ADDRESSES: Online submissions: http://effective healthcare.AHRQ.gov/index.cfm/submit scientific-information-packets/. Please select the study for which you are submitting information from the list of current studies and complete the form to upload your documents. Email submissions: ehcsrc@ohsu.edu (please do not send zipped files—they are automatically deleted for security reasons). Print submissions: Robin Paynter, Oregon Health and Science University, Oregon Evidence-based Practice Center, 3181 SW Sam Jackson Park Road, Mail Code: BICC, Portland, OR 97239–3098. FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, Telephone: 503–494–0147 or Email: ehcsrc@ohsu.edu. SUPPLEMENTARY INFORMATION: In accordance with Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173, the Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidence-based Practice Centers to complete a comparative effectiveness review of the evidence for local therapies for unresectable primary hepatocellular carcinoma. The EHC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by systematically requesting information (e.g., details of studies conducted) from medical device PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 3,184,333 Annualized cost 1,061,444 industry stakeholders through public information requests, including via the Federal Register and direct postal and/ or online solicitations. We are looking for studies that report on local therapies for unresectable primary hepatocellular carcinoma, including those that describe adverse events, as specified in the key questions detailed below. The entire research protocol, including the key questions, is also available online at: http://www.effective healthcare.AHRQ.gov/index.cfm/ search-for-quides-reviews-and-reports/ ?productid=1012&pageaction=display product#5056. This notice is a request for industry stakeholders to submit the following: • A current product label, if applicable (preferably an electronic PDF file). • Information identifying published randomized controlled trials and observational studies relevant to the clinical outcomes. Please provide both a list of citations and reprints if possible. • Information identifying unpublished randomized controlled trials and observational studies relevant to the clinical outcomes. If possible, please provide a summary that includes the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/ enrolled/lost to withdrawn/follow-up/ analyzed, and effectiveness/efficacy and safety results. • Registered ClinicalTrials.gov studies. Please provide a list including the ClinicalTrials.gov identifier, condition, and intervention. Your contribution is very beneficial to this program. AHRQ is not requesting and will not consider marketing material, health economics information, or information on other indications. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. In addition to your scientific information please submit an index document outlining the relevant information in each file along with a statement regarding whether or not the submission comprises all of the complete information available. E:\FR\FM\26APN1.SGM 26APN1

Agencies

[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24957-24959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10009]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


 Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project: ``American Recovery and Reinvestment Act ``Developing a 
Registry of Registries''.'' In accordance with the Paperwork Reduction 
Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this 
proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on February 23, 2012 and allowed 60 days for 
public comment. No comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by May 29, 2012.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
email at OIRA_submission@omb.eop.gov (attention: AHRQ's desk officer).
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Proposed Project

American Recovery and Reinvestment Act ``Developing a Registry of 
Registries''

    The Food and Drug Administration Modernization Act of 1997, Public 
Law 105-115, provided for the creation of a Clinical Trials Data Bank, 
known as ClinicalTrials.gov. Since its launch in 2000, the 
ClinicalTrials.gov system has registered over 90,500 trials. The large 
volume of studies currently listed in ClinicalTrials.gov and the high 
usage numbers suggest that the system has been successful at improving 
access to information about clinical studies. However, while 
ClinicalTrials.gov supports the listing of observational studies, such 
listing is not required.
    Patient registries are a distinct type of observational study. 
Patient registries may be designed for many purposes, such as to 
observe the natural history of disease, examine comparative 
effectiveness, or fulfill post-approval commitments. Patient registries 
have specific characteristics that are not currently captured on 
ClinicalTrials.gov. To date, some registry sponsors have attempted to 
leverage the observational study model to post patient registry-type 
records on ClinicalTrials.gov. However, stakeholders have noted that 
the system does not fully meet their needs.
    Patient registries have received significant attention and funding 
in recent years. Similar to controlled interventional studies, patient 
registries represent some burden to patients (e.g., time to complete 
patient reported outcome measures, risk of loss of privacy), who often 
participate voluntarily in hopes of improving knowledge about a disease 
or condition. Patient registries also represent a substantial 
investment of health research resources. Despite these factors, 
registration of patient registries in ClinicalTrials.gov is not 
currently required, presenting the potential for duplication of efforts 
and insufficient dissemination of findings that are not published in 
the peer-reviewed literature. To ensure that resources are used in the 
most efficient manner, registries need to be listed in a manner similar 
to that of trials in ClinicalTrials.gov.
    By creating a central point of collection for information about all 
patient registries in the United States, the Registry of Patient 
Registries (RoPR) helps to further AHRQ's goals by making information 
regarding quality, appropriateness, and effectiveness of health 
services (and patient registries in particular) more readily available 
and centralized.
    The primary goal of this project is to engage stakeholders in the 
design and development of a RoPR database system that is compatible 
with ClinicalTrials.gov and meets the following objectives:
    (1) Provides a searchable database of patient registries in the 
United States (to promote collaboration, reduce redundancy, and improve 
transparency);
    (2) Facilitates the use of common data fields and definitions in 
similar health conditions (to improve opportunities for sharing, 
comparing, and linkage);
    (3) Provides a public repository of searchable summary results 
(including

[[Page 24958]]

results from registries that have not yet been published in the peer-
reviewed literature);
    (4) Offers a search tool to locate existing data that researchers 
can request for use in new studies; and serves as a recruitment tool 
for researchers and patients interested in participating in patient 
registries.
    This study is being conducted by AHRQ through its contractor, the 
Outcome DEcIDE Center, pursuant to the American Recovery and 
Reinvestment Act, Public Law 111-5, and pursuant to AHRQ's statutory 
authority to conduct and support research and disseminate information 
on health care and on systems for the delivery of such care, including 
activities with respect to the quality, effectiveness, efficiency, 
appropriateness and value of health care services and with respect to 
database development. 42 U.S.C. 299a(a)(1) and (8).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
    (1) Collect information from registry holders, defining a patient 
registry profile via a web-based interface, to populate the RoPR 
database system.
    The purpose of the RoPR is to create a readily available public 
resource in the model of ClinicalTrials.gov to share information on 
existing patient registries to promote collaboration, reduce 
redundancy, and improve transparency in registry research. Patient 
registry research has become more prevalent and, based on stakeholder 
feedback, is not adequately served by ClinicalTrials.gov at present. 
The information being collected in the RoPR record will be visible to 
the public visiting the RoPR Web site and will be available for public 
use in this capacity.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden for the 
respondents' time to participate in the RoPR. Because the RoPR is a 
voluntary system available to any entity conducting a patient registry, 
it is not possible to determine the number of potential respondents. We 
do know that over 3,800 newly registered records designated as 
``observational studies'' were entered into ClinicalTrials.gov in 2010. 
Only a subset of this number (which we will estimate at a maximum of 
40%) would qualify as patient registries and would likely be registered 
in the RoPR. Therefore, we use 1,520 (3,800*0.40) in Exhibits 1 and 2 
below as a very rough, but high, estimation of the potential number of 
respondents who will enter registries into the RoPR annually. The 
actual number of respondents will depend on a variety of factors and 
could vary widely. It should be remembered that mandates could evolve 
making registration in the RoPR mandatory. Our estimates therefore 
attempt to factor an upper threshold for volume.
    Each respondent will enter a new RoPR record only once and is 
estimated to take 45 minutes. An estimated 50% (760 records) of RoPR 
records will be updated once a year and will take about 15 minutes. 
This estimate is based on a query of ClinicalTrials.gov which showed 
that about 50% of observational studies registered in 
ClinicalTrials.gov had been updated in the past year. The total 
respondent burden is estimated to be 1,330 hours annually.
    Exhibit 2 shows the estimated cost burden associated with the 
respondent's time to participate in the RoPR. The total cost burden is 
estimated to be $45,579 annually.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
New RoPR Record.................................           1,520               1           45/60           1,140
Review/update RoPR Record.......................             760               1           15/60             190
                                                 ---------------------------------------------------------------
    Total.......................................           2,280              na              na           1,330
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden       Average       Total cost
                    Form Name                       respondents        hours       hourly rate +      burden
----------------------------------------------------------------------------------------------------------------
New RoPR Record.................................           1,520           1,140          $34.27         $39,068
Review/update RoPR Record.......................             760             190           34.27           6,511
                                                 ---------------------------------------------------------------
    Total.......................................           2,280           1,330              na         $45,579
----------------------------------------------------------------------------------------------------------------
+ Based upon the mean average wage for Healthcare Practitioners and Technical Occupations, May 2010 National
  Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of Labor Statistics. Available
  at: http://www.bls.gov/oes/current/oes_nat.htm#29-0000.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the estimated total and annualized cost to the 
government to create and maintain the RoPR for 3 years. The total cost 
is estimated to be $3,184,333.

             Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
                                                            Annualized
             Cost component                 Total cost         cost
------------------------------------------------------------------------
Project Development.....................      $2,318,509        $772,836
Project Management......................         409,149         136,383
Overhead................................         456,675         152,225
                                         -------------------------------

[[Page 24959]]

 
    Total...............................       3,184,333       1,061,444
------------------------------------------------------------------------

Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of AHRQ healthcare research and 
healthcare information dissemination functions, including whether the 
information will have practical utility; (b) the accuracy of AHRQ's 
estimate of burden (including hours and costs) of the proposed 
collection(s) of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the Agency's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

    Dated: April 19, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-10009 Filed 4-25-12; 8:45 am]
BILLING CODE 4160-90-M